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Recruiting
NCT07791576
Population PK-guided ATG Dosing in Haplo-HSCT
Conditions: Hematopoietic Stem Cell Transplantation
Sex: All
Ages: 14 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 63
Sponsor: Chinese PLA General Hospital
Location: Chinese PLA General Hospital Beijing Beijing Municipality
Summary
To evaluate the safety and efficacy of a population pharmacokinetics (PK)-guided targeted ATG dosing strategy in haploidentical stem cell transplantation and to observe the GVHD-free, relapse-free survival (GRFS) in the cohort receiving this strategy.
Eligibility Criteria
Inclusion Criteria:
1. Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation.
2. Have an HLA-matched sibling, unrelated, or haploidentical donor.
3. Age ≥ 14 years and ≤ 65 years.
4. Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal.
5. Renal function: creatinine ≤ upper limit of normal.
6. No uncontrolled infection or severe mental or psychological disorders.
7. ECOG performance status score of 0-2.
8. Signed informed consent.
Exclusion Criteria:
1. No HLA-matched donor.
2. Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status,or second transplantation.
3. Patient age \< 14 years or \> 65 years.
4. Pregnancy of either the donor or the recipient.
5. Presence of mental illness or other conditions that preclude compliance with the protocol.
Source: ClinicalTrials.gov (NCT07791576). StuddyBuddy aggregates publicly available trial information.